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Uses: Preferred test to identify alpha-1-antitrypsin deficiency and causative DNA and protein variants. Congenital deficiency of  Alpha-1-Antitrypsin is associated with early lung disease, Neonatal hepatitis and Infantile cirrhosis

Method: Nephelometry, Immunoturbidimetry, Polymerase Chain Reaction, Fluorescence Monitoring, Isoelectric Focusing, ELISA

Category: Genetic Disorders

Reference: Alpha-1-Antitrypsin Stool-Clearance: 1 – 49 mL/24h
Alpha-1-Antitrypsin, Quantitative by ELISA, Random Stool: 0.00 – 0.50 mg/g
Alpha-1-Antitrypsin: 90-200 mg/dL

Pre-test Information: No special preparation required

Specimen Collection: 2 mL (0.5 mL min.) serum from 1 Red tube. Do not use SST gel barrier tubes. Separate serum from cells immediately. Ship refrigerated or frozen or lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B) tube. 

Alpha-1-Antitrypsin Clearance, Quantitative by ELISA, Timed Stool: Entire 24-, 48-, or 72-hour stool collection. Refrigerate during collection. Collect blood during the stool collection time interval. Allow serum to clot completely at room temperature. Separate from cells ASAP or within 2 hours of collection

Storage: Frozen

Stability: Serum: Ambient: 1 week; Refrigerated: 3 months; Frozen: 3 months (avoid repeat freeze/thaw cycles)
Whole Blood: Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 month

Report Availability: Same day-10 days

More Details: Alpha-1-Antitrypsin (AAT) is a protease inhibitor which has the capacity to combine with and inactivate trypsin. It also neutralizes the activity of other proteases like elastase and hence is an intrinsic factor in the homeostatic mechanism modulating endogenous proteolysis. Deficiency of AAT is seen in Pulmonary emphysema and in children with Cirrhosis. At least 75 different alleles exist for AAT of which about 17 alleles are associated with pulmonary disease and only a few are responsible for liver disease. Elevated AAT levels are due to acute-phase reaction to inflammation and infections which is not linked to genetic defects. High values are also seen during pregnancy and on oral contraceptives

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Uses: Use to detect the 2019 novel coronavirus (SARS-CoV-2) that causes COVID-19

Method: Real-Time PCR, ELISA, Qualitative Nucleic Acid Amplification, Antibody (serology) test

Category: Viral Infections

Reference: COVID-19 test by RT-PCR: Positive: RNA specific to SARS-CoV-2 detected, Negative: RNA specific to SARS-CoV-2 not detected, Inconclusive: This could be due to the low viral load in the sample. A repeat sample is recommended for confirmation

COVID-19 IgG by ELISA: Negative: 0.7 Index or less
Indeterminate: 0.8-1.0 Index 
Positive: 1.1 Index or greater

Pre-test Information: Duly filled Covid-19 clinical information form (form 44) is mandatory.

Specimen: Submit oropharyngeal & nasopharyngeal Swab/ ET secretions/ BAL / Sputum inoculated in special viral transport medium. Duly filled Covid-19 documentation as mandated by GOI is mandatory. A blood sample is drawn from a vein or is collected from a fingerstick for an antibody test in Red tube.

Storage: Refrigerated

Stability: Stability Room: 2 hrs
Stability Refrigerated: 72 hrs
Stability Frozen: 1 month

Report: 1-5 days

More details: This test is useful for the detection of coronavirus. Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronavirus disease (COVID-19) is a new strain that was discovered in 2019 and has not been previously identified in humans. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, an infection can cause pneumonia, severe acute respiratory syndrome and kidney failure. A negative result does not rule out the possibility of Covid-19 infection. Presence of inhibitors, mutations & insufficient RNA specific to SARS-CoV-2 can influence the test result. Kindly correlate the results with clinical findings. A negative result in a single upper respiratory tract sample does not rule out SARS-CoV-2 infection. Hence in such cases, a repeat sample should be sent. Covid-19 Test conducted as per kits approved by ICMR / CE-IVD / USFDA. Kindly consult referring Physician / Authorized hospitals for appropriate follow up. Also Known As Coronavirus 2019 Test SARS CoV-2 Test COVID-19 RT-PCR COVID-19 IgG, IgM antibody test SARS CoV-2 antigen test COVID-19 Ag test. Formal Name Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) RNA Detection by RT-PCR, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibody, Serum COVID-19 Antigen test. 

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Uses: Order to diagnose hemophilia A, acquired factor VIII deficiency, or as part of a diagnostic workup for von Willebrand disease (VWD). Also useful for monitoring treatment in patients with factor VIII deficiency or VWD. Not recommended when screening for thrombophilia.

Method: Electromagnetic Mechanical Clot Detection

Category: Coagulation Disorders, Hematology

Reference: Normal

Abnormal in hemophilia >5% Mild, 1-5% Moderate, <1% Severe

Pre-test Information: Overnight fasting is preferred. Give a brief clinical history. It is recommended that patient discontinues Heparin for 1 day & Oral Anticoagulants for 7 days prior to sampling as these drugs may affect test results. Discontinuation should be with prior consent from the treating Physician.

Specimen Collection: 3 mL Whole blood in 1 Blue tube (Sodium Citrate). Mix thoroughly by inversion. Transport to Lab within 4 hrs. If this is not possible, make PPP within 1 hour of the collection as follows: Centrifuge sample at 3600 rpm for 15 min & transfer supernatant to a clean plastic tube. Centrifuge this supernatant again at 3600 rpm for 15 mins & finally transfer the supernatant (PPP) to 1 labelled clean plastic screw-capped vial. FREEZE IMMEDIATELY. Ship frozen. DO NOT THAW. Overnight fasting is preferred. Duly filled Coagulation Requisition Form is mandatory.

Storage: Critical frozen

Stability: Stability Room 4 hrs
Stability Refrigerated 4 hrs
Stability Frozen 2 weeks

Report Availability: 1-3 days

More Details: Other names that describe the test. Antihemophilic Factor (AHF), Factor VIII:C (Coagulant Portion) Coagulation Factor VIII Activity Assay,Plasma Factor VIII Activity Assay, Intrinsic Factor Proteins, Intrinsic Factors, Factor 8 deficiency test. Ageing, pregnancy, OCP use & oestrogen replacement therapy can increase Factor VIII levels.

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Uses: Tumor marker for diagnosing lung cancer. Monitoring the course of Non-small cell lung cancer (NSCLC) & course monitoring in Myoinvasive Bladder cancer

Method: Quantitative ELISA, Electrochemiluminescence, Immunoradiometric Assay

Category: Cancer, Oncology

Reference:  Normal < 3.30 ng/mL, Elevated > 3.30 ng/ml

Pre-test Information: Provide a brief clinical history. No special preparation required

Specimen Collection: 2 mL (0.5 mL min.) serum from 1 SST. Ship refrigerated or frozen. Allow serum specimen to clot completely at room temperature. Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to plain Red tube.

Storage: Refrigerated

Stability: Stability Room 2 hrs
Stability Refrigerated 4 weeks
Stability Frozen 2 months (avoid repeated freeze/thaw cycles)

Report Availability: Same day – 8 days

More Details: CYFRA 21–1 is a sensitive and specific tumor marker of non-small-cell lung cancer (NSCLC), especially of squamous cell subtype. It also reflects the extent of the disease and has an independent prognostic role along with performance status and disease stage in NSCLC. In addition, detection of serum CYFRA 21–1 allows for the identification of high-risk patients that may benefit from adjuvant chemotherapy and enables the early detection of progressive disease in recurrent NSCLC. Additionally, CYFRA 21–1 has been described as a useful marker for oesophagal squamous cell carcinoma and for therapy monitoring of bladder cancer. This test is not recommended for the primary diagnosis of Lung cancer. Patients receiving Biotin therapy in high doses should not be tested for at least 8 hours after the last dose. Levels greater than 30 ng/mL are highly indicative of Primary Bronchial carcinoma. Increased Levels are also found in  Non-Small cell carcinoma lung, Acute pneumonia, Tuberculosis, Interstitial lung disease, Liver cirrhosis & Renal failure.

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Uses:  Quantitative detection of (1-3)-β-D-Glucan (BDG) in serum samples which signifies the presence of invasive fungal infection. It has got both diagnostic and prognostic application.

Method: Spectrophotometry, Semi-Quantitative Colorimetry

Category: Fungal Infections, Mycology

Reference: Less than 59 pg/mL: Negative
60-79 pg/mL: Indeterminate
Greater than or equal to 80 pg/mL: Positive

Pre-test Information: No special preparation required

Specimen Collection: 2 mL (1 mL min.) serum in 1 Red tube (No additive) preferably Glucan free OR 2 mL (1 mL min.) BAL fluid in a sterile screw capped container OR 1 mL (0.5 mL min.) CSF in a sterile screw capped container. Ship refrigerated or frozen.

Storage: Refrigerated

Stability: Stability Room: 2 hrs
Stability Refrigerated: 48 hrs
Stability Frozen: 2 weeks

Report Availability: Same day – 3 days

More Details: It is indicated for presumptive diagnosis of fungal infection ( eg, P. jirovecii, Aspergillus, or Candida) & should be used in conjunction with other diagnostic procedures. This test does not detect certain fungal species such as Cryptococcus, which produce very low levels of (1,3)-beta-D-glucan. This test will not detect the zygomycetes, such as Absidia, Mucor, and Rhizopus, which are not known to produce (1,3)-beta-D-glucan. In addition, the yeast phase of Blastomyces dermatitidis produces little (1,3)-beta-D-glucan and may not be detected by the assay.